UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028302
Receipt No. R000032128
Scientific Title Single-dose-administration study of GT-02037 subcutaneous injection in healthy Japanese male subjects
Date of disclosure of the study information 2017/07/20
Last modified on 2017/11/01

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Single-dose-administration study of GT-02037 subcutaneous injection in healthy Japanese male subjects
Acronym GT-02037 single dose study
Scientific Title Single-dose-administration study of GT-02037 subcutaneous injection in healthy Japanese male subjects
Scientific Title:Acronym GT-02037 single dose study
Region
Japan

Condition
Condition Acromegaly
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Primary objective
Investigation for safety of GT-02037 in male healthy adult subjects.
Secondary objective
Investigation for pharmacokinetics of GT-02037.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Safety of GT863
Physical examination (The day prior to administration (Day-1), Pre, 1*, 4, 24, 48hours, Follow up (Day7) )
Injection site reaction (Pre, 1*, 4, 24, 48hours, Day7)
Vital sign (Day-1, Pre, 1*, 4, 24, 48hours, Day7)
Electrocardiogram (Day-1, 1*, 4, 24hours, Day7)
SpO2 (Pre, 15minutes)
Laboratory examination (Day-1, 24hours, Day7)
Adverse event
* Only Step 1
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 GT-02037 (0.1, 0.5, 1.0, 2.0mg) single dose
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
40 years-old >=
Gender Male
Key inclusion criteria (1) Japanese male healthy adult subjects
(2) between 20 and 40 years old
(3) Body weight over 50 kg
(4) BMI over 18.5 under 25.0 kg/m2
(5) Having given written informed consent prior to any procedure related to the study
Key exclusion criteria (1) Any subject who have present and/or past history of disease of heart and circulatory system, liver, kidney, digestive system, and blood system, central nerves system, respiratory system.
(2) Hypersensitivity or Idiosyncratic to drugs
(3) History of allergy to any clinically important allergy
(4) A constitution prone to hypersensitivity reaction such as rash (erythema, wheal, etc)
(5) Any subject have present and/or past history of drug and alcohol addiction.
(6) Positive serologic findings for treponema pallidum (syphilis), human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg),and/or hepatitis C virus (HCV) antibodies.
(7) Positive findings of urine drug screen.
(8) Any drug history within 2weeks before study day 1.
(9) Use of any investigational drug within 16weeks before study day 1.
(10) Donation of blood over 400mL within 14 weeks, 200mL within 4weeks before study day 1. Blood compornent donation within 2weeks.
(11) Any subject not able to agree to make contraception during the study.
(12) A past medical history of somatostatin analog administration
(13) Any clinically important deviation from normal limits in physical examination, vital signs, 12-lead electrocardiograms (ECGs), or clinical laboratory test results.
(14) Subjects deemed by the investigator to be inappropriate according for inclusion in the study.
Target sample size 24

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Setsuo Hasegawa
Organization Pharmaspur Inc.
Division name Internal medicine
Zip code
Address 1-2-10 Nihonbashi. Chuo-ku, Tokyo, Japan
TEL 03-6214-2670
Email setsuo_hasegawa@pharmaspur.com

Public contact
Name of contact person
1st name
Middle name
Last name Ayaka Kiyota
Organization Pharmaspur Inc.
Division name Clinical study
Zip code
Address 1-2-10 Nihonbashi. Chuo-ku, Tokyo, Japan
TEL 03-6214-2670
Homepage URL
Email ayaka_kiyota@pharmaspur.com

Sponsor
Institute Pharmaspur Inc.
Institute
Department

Funding Source
Organization Gly Tech, Inc.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 20 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2017 Year 07 Month 10 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 07 Month 20 Day
Last modified on
2017 Year 11 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032128

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.